FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma

Exclusion Criteria

• •Known hypersensitivity or allergy to Oxaliplatin, Fluorouracil, Leucovorin, Donafenib, Pucotenlimab, or any of their excipients.
• •Previous treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other immunomodulatory agents.
• •Diagnosis of other malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
• •Presence of central nervous system (CNS) metastases.
• •Active, known, or suspected autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring systemic treatment.
• •History of gastrointestinal bleeding, esophageal or gastric varices with bleeding risk, or other active bleeding within 6 months prior to enrollment.
• •Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, or uncontrolled hypertension.
• •Active infection requiring systemic antibiotic therapy.
• •Hepatitis B virus (HBV) DNA \> 2000 IU/mL (participants must receive antiviral treatment to suppress viral load).
• •Known Human Immunodeficiency Virus (HIV) infection or active Syphilis infection.
• •Anatomy unsuitable for hepatic arterial catheterization (e.g., severe vascular variation or occlusion).
• •Pregnant or breastfeeding women.
• •Any condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the integrity of the study data.